一项针对中度至重度类风湿性关节炎参与者的研究 (RA-BEGIN)
2019年9月9日 更新者：Eli Lilly and Company
一项随机、双盲、主动控制的 3 期研究，旨在评估 Baricitinib (LY3009104) 在中度至重度活动性类风湿性关节炎患者中的疗效和安全性，这些患者的疾病缓解抗风湿药物治疗有限或未进行治疗
本研究的目的是确定单独巴瑞克替尼治疗是否不劣于单独使用甲氨蝶呤 (MTX) 治疗中度至重度活动性类风湿关节炎 (RA)，这些患者接受过有限或未接受过 MTX 治疗且未接受其他药物治疗常规或生物疾病缓解抗风湿药 (DMARD)。
研究概览
研究类型
介入性
注册 (实际的)
588
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Moscow、俄罗斯联邦、115522
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Ryazan、俄罗斯联邦、390026
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Ulyanovsk、俄罗斯联邦、432063
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Yaroslavl、俄罗斯联邦、150003
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Alberta
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Edmonton、Alberta、加拿大、T5M 0H4
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British Columbia
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Victoria、British Columbia、加拿大、V8V 3P9
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Manitoba
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Winnipeg、Manitoba、加拿大、R3A 1M3
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Ontario
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Kitchener、Ontario、加拿大、N2M 5N6
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Ottawa、Ontario、加拿大、K1H 1A2
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St. Catherines、Ontario、加拿大、L2N 7E4
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Quebec
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Trois-Rivieres、Quebec、加拿大、G8Z 1Y2
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7K 0H6
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Bloemfontein、南非、9301
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Durban、南非、4092
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Greenacres、南非、6057
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Somerset West、南非、7135
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Stellenbosch、南非、7600
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Ahmedabad、印度、532004
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Attavar, Mangalore、印度、575001
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Bangalore、印度、560 054
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Belgaum、印度、590 010
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Hyderabaad、印度、500072
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Jaipur、印度、302006
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Kolkata、印度、700 020
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Lucknow、印度、226 014
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Mumbai、印度、400053
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New Delhi、印度、110 076
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Guadalajara、墨西哥、44620
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Monterrey、墨西哥、64040
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San Luis Potosi、墨西哥、78213
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Daejeon、大韩民国、301-721
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Incheon、大韩民国、405-760
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Seoul、大韩民国、134-727
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Vienna、奥地利、1100
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Curitiba、巴西、80030-110
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Goiania、巴西、74110-120
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São Paulo、巴西、04266-010
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Ampelokipoi、希腊、11527
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Heraklion、希腊、71110
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Kifissia、希腊、14561
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Larissa、希腊、41221
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Bad Nauheim、德国、61231
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Bayreuth、德国、95444
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Berlin、德国、13125
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Gommern、德国、39245
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Hamburg、德国、22081
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Munich、德国、80336
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Firenze、意大利、50139
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Genova、意大利、16132
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Milano、意大利、20157
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Monza、意大利、20900
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Torino、意大利、10154
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Valeggio Sul Mincio、意大利、37067
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Aichi、日本、466-8560
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Chiba、日本、284-0003
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Fukuoka、日本、807-8556
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Hiroshima、日本、733-0032
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Hokkaido、日本、063-0811
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Hyogo、日本、665-0827
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Ibaragi、日本、316-0015
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Iwate、日本、020-0015
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Japan、日本、275-8580
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Kagawa、日本、761-0793
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Kagoshima、日本、899-5117
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Kanagawa、日本、236-0004
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Kumamoto、日本、861-1196
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Mie、日本、510-0016
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Nagano、日本、380-8582
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Nagasaki、日本、857-1195
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Niigata、日本、940-2085
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Okayama、日本、700-8607
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Okinawa、日本、901-0243
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Saitama、日本、359-1111
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Shizuoka、日本、430-8558
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Tokyo、日本、160-8582
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Toyama、日本、933-0874
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Brussel、比利时、1200
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Genk、比利时、3600
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Gent、比利时、9000
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Liège、比利时、4000
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Mons、比利时、7000
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Caguas、波多黎各、00725
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Carolina、波多黎各、00983
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San German、波多黎各、00683
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San Juan、波多黎各、00927
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Santurce、波多黎各、00909
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Göteborg、瑞典、SE 413 45
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Huddinge、瑞典、141 87
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Malmo、瑞典、SE-20502
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Arizona
-
Glendale、Arizona、美国、85304
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-
Mesa、Arizona、美国、85202
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Peoria、Arizona、美国、85381
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Phoenix、Arizona、美国、85037
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California
-
El Cajon、California、美国、92020
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Lakewood、California、美国、90712
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Palm Desert、California、美国、92260
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Tustin、California、美国、92780
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Upland、California、美国、91786
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Colorado
-
Boulder、Colorado、美国、80304
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Connecticut
-
Trumbull、Connecticut、美国、06611
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-
Delaware
-
Lewes、Delaware、美国、19958
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-
Florida
-
Boynton Beach、Florida、美国、33472
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-
Naples、Florida、美国、34102
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-
Orlando、Florida、美国、32806
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-
Palm Harbor、Florida、美国、34684
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Plantation、Florida、美国、33324
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Tampa、Florida、美国、33614
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-
Venice、Florida、美国、34292
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Illinois
-
Vernon Hills、Illinois、美国、60061
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Indiana
-
Indianapolis、Indiana、美国、46260
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Maryland
-
Cumberland、Maryland、美国、21502
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Michigan
-
Grand Rapids、Michigan、美国、49546
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Lansing、Michigan、美国、48910
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Mississippi
-
Flowood、Mississippi、美国、39232
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Missouri
-
Saint Louis、Missouri、美国、63141
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New Jersey
-
Freehold、New Jersey、美国、07728
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-
Toms River、New Jersey、美国、08755
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-
New Mexico
-
Albuquerque、New Mexico、美国、87102
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New York
-
Hartsdale、New York、美国、10530
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Ohio
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Middleburg Heights、Ohio、美国、44130
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Oklahoma
-
Oklahoma City、Oklahoma、美国、73103
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-
Tulsa、Oklahoma、美国、74135
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-
-
Oregon
-
Portland、Oregon、美国、97239
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
-
Duncansville、Pennsylvania、美国、16635
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-
Wyomissing、Pennsylvania、美国、19610
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-
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Tennessee
-
Jackson、Tennessee、美国、38305
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
-
Dallas、Texas、美国、75231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Grapevine、Texas、美国、76051
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-
Houston、Texas、美国、77084
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-
Lubbock、Texas、美国、79424
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Nassau Bay、Texas、美国、77058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
-
Chesapeake、Virginia、美国、23320
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
-
Kennewick、Washington、美国、99336
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-
Vancouver、Washington、美国、98664
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West Virginia
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Clarksburg、West Virginia、美国、26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
-
Franklin、Wisconsin、美国、53132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cambridgeshire
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Cambridge、Cambridgeshire、英国、CB2 0QQ
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Greater London
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London、Greater London、英国、SE1 9RT
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Hampshire
-
Basingstoke、Hampshire、英国、RG24 9NA
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-
Hants
-
Southampton、Hants、英国、SO16 6YD
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Tyneside
-
North Shields、Tyneside、英国、NE29 8NH
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Lisbon、葡萄牙、1050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Porto、葡萄牙、4200-319
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Buenos Aires、阿根廷、C1128AAF
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Caba、阿根廷、C1440AAD
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Córdoba、阿根廷、5000
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-
La Plata、阿根廷、B1902COS
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-
Mar Del Plata、阿根廷、B7600FZN
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-
Quilmes、阿根廷、1878
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Rosario、阿根廷、2000
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San Fernando、阿根廷、1646
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-
San Juan、阿根廷、5400
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San Miguel De Tucuman、阿根廷、T4000AXL
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-
Tucuman、阿根廷、4000
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 根据美国风湿病学会/欧洲抗风湿病联盟 (ACR/EULAR) 2010 年 RA 分类标准的定义，诊断为成人型类风湿性关节炎 (RA)
- 有记录的类风湿因子和/或环瓜氨酸肽 (CCP) 抗体测试阳性病史
- 具有中度至重度活动性 RA，定义为存在至少 6/68 个触痛关节和至少 6/66 个肿胀关节
- C 反应蛋白 (CRP) 或高敏 C 反应蛋白 (hsCRP) 测量值≥正常值上限 (ULN) 的 1.2 倍
- 甲氨蝶呤 (MTX) 治疗有限或未接受过治疗
排除标准：
- 已接受除 MTX 以外的常规疾病缓解抗风湿药 (DMARD)（例如，金盐、环孢菌素、来氟米特、硫唑嘌呤、羟氯喹、柳氮磺胺吡啶或任何其他免疫抑制剂）
- 目前正在接受剂量 > 10 mg/d 的泼尼松（或等效药物）剂量的皮质类固醇，或在进入研究后 2 周内或计划随机分组后 6 周内接受不稳定剂量的皮质类固醇
- 在进入研究后 2 周内或计划随机分组后 6 周内开始使用非甾体抗炎药 (NSAIDs) 治疗或接受不稳定的 NSAIDs 给药方案
- 在进入研究之前的 2 周内开始了新的 RA 物理治疗
- 曾经接受过任何生物 DMARD
- 在进入研究前 4 周内接受过干扰素治疗或预计在研究期间需要干扰素治疗
- 在进入研究前 2 周内或计划随机分组前 6 周内接受过任何通过肌肉内或静脉内 (IV) 注射的肠外皮质类固醇，或预计在研究期间需要肠外注射皮质类固醇
- 在进入研究前 2 周内或计划随机分组前 6 周内，有 3 个或更多关节注射了关节内皮质类固醇或透明质酸
- 有活动性纤维肌痛，在研究者看来，这将使得难以为本研究的目的适当评估 RA 活动
- 诊断出除 RA 以外的任何全身炎症性疾病，例如但不限于幼年型慢性关节炎、脊柱关节病、克罗恩病、溃疡性结肠炎、银屑病关节炎、活动性血管炎或痛风（不排除患有继发性干燥综合征的参与者。 )
- 诊断为 Felty 综合征
- 在进入研究后的 8 周内接受过任何大手术，或者在研究期间需要进行大手术，研究者在与礼来公司或其指定人员协商后认为会对参与者造成不可接受的风险
- 在进入研究后的 12 周内经历过以下任何一种情况：心肌梗塞、不稳定的缺血性心脏病、中风或纽约心脏协会 IV 期心力衰竭
- 有心血管、呼吸系统、肝脏、胃肠道、内分泌、血液学、神经学或神经精神疾病或任何其他严重和/或不稳定疾病的病史或存在，研究者认为这些疾病可能在服用研究产品时构成风险或可能会干扰数据的解释
- 大部分或完全丧失行为能力，几乎无法自理，例如卧床不起或只能坐在轮椅上
- 根据最近可用的血清肌酐使用肾病饮食改良法 (MDRD) 估计肾小球滤过率 (eGFR) <40 毫升每分钟每 1.73 m^2 (mL/min/1.73 米^2)
- 有慢性肝病病史，最近可用的天冬氨酸转氨酶 (AST) 或丙氨酸转氨酶 (ALT) > ULN 的 1.5 倍或最近可用的总胆红素 ≥ ULN 的 1.5 倍
- 有淋巴增生性疾病病史；或有提示可能存在淋巴增生性疾病的体征或症状，包括淋巴结肿大或脾肿大；或患有活动性原发性或复发性恶性疾病；或临床上显着的恶性肿瘤已缓解 <5 年
- 在计划随机化之前的 12 周内已经接触过活疫苗，或者预计在研究过程中需要/接受活疫苗（带状疱疹疫苗接种除外）
- 目前或最近有临床上严重的病毒、细菌、真菌或寄生虫感染
- 在进入研究前 12 周内曾有症状性带状疱疹感染
- 有播散性/复杂性带状疱疹病史（例如，多皮节受累、眼部带状疱疹、中枢神经系统受累、带状疱疹后遗神经痛）
- 免疫功能低下，并且研究者认为参与研究的风险不可接受
- 有活动性乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）或人类免疫缺陷病毒（HIV）病史
- 筛选实验室测试值，包括促甲状腺激素 (TSH)，超出人群或研究地点的参考范围，研究者认为这对参与者参与研究构成不可接受的风险
- 筛查心电图 (ECG) 异常，研究者或申办者认为这些异常具有临床意义，表明参与者参与研究存在不可接受的风险
- 在参加研究时患有有症状的单纯疱疹
- 有活动性或潜伏性结核病 (TB) 的证据
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：巴瑞克替尼 + 甲氨蝶呤
Baricitinib 4 毫克 (mg)，每天口服一次，直至第 52 周。
参与者每周口服一次甲氨蝶呤 (MTX)，剂量范围为每周 10 至 20 毫克，直至第 52 周。
从第 24 周开始，无反应的参与者每天口服 4 毫克巴瑞克替尼，每周口服一次甲氨蝶呤。
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口服给药
其他名称：
口服给药
每天口服给药
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实验性的：巴瑞克替尼
Baricitinib 4 mg，每天口服一次，直至第 52 周。
参与者每周口服一次 MTX 安慰剂，直至第 52 周。
从第 24 周开始，无反应的参与者每天口服 4 毫克巴瑞克替尼，每周口服一次甲氨蝶呤。
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口服给药
其他名称：
每天口服给药
MTX 安慰剂每周口服一次。
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有源比较器：甲氨蝶呤
MTX 每周口服一次，剂量范围为每周 10 至 20 毫克，直至第 52 周。
参与者还每天口服一次 baricitinib 安慰剂。
从第 24 周开始，无反应的参与者每天口服 4 毫克巴瑞克替尼，每周口服一次甲氨蝶呤。
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口服给药
每天口服给药
Baricitinib 安慰剂每天口服一次。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
达到美国风湿病学会 20% 改善 (ACR20) 的参与者百分比
大体时间：第 24 周
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ACR20 反应指数是类风湿性关节炎 (RA) 的临床、实验室和功能测量的综合结果。
“ACR20 响应者”是指在压痛和肿胀关节计数方面至少有 20% 改善并且符合以下 5 项标准中的至少 3 项的参与者：医生对疾病活动的整体评估、患者使用视觉模拟量表对疾病活动的整体评估（ VAS）、健康评估问卷-残疾指数（HAQ-DI）、关节炎引起的疼痛和高敏 C 反应蛋白（hsCRP）。
反应缺失的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
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第 24 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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达到美国风湿病学会 20% 改善 (ACR20) 的参与者百分比
大体时间：第 52 周
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ACR20 反应指数是类风湿性关节炎 (RA) 的临床、实验室和功能测量的综合结果。
“ACR20 响应者”是指在压痛和肿胀关节计数方面至少有 20% 改善并且符合以下 5 项标准中的至少 3 项的参与者：医生对疾病活动的整体评估、患者使用视觉模拟量表对疾病活动的整体评估（ VAS）、健康评估问卷-残疾指数（HAQ-DI）、关节炎引起的疼痛和高敏 C 反应蛋白（hsCRP）。
反应缺失的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
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第 52 周
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健康评估问卷-残疾指数 (HAQ-DI) 分数相对于基线的变化
大体时间：基线，第 24 周
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HAQ-DI 评估参与者在穿衣和打扮时的困难程度 [0（没有任何困难），1（有一些困难），2（有很大困难）和 3（不能做）]，出现、吃饭、走路、卫生、伸手、抓握和进行其他日常活动。
每个功能领域的分数被平均以计算 HAQ-DI 分数，其范围从 0（无残疾）到 3（最严重的残疾）。
HAQ-DI 分数的下降表明参与者的状况有所改善。
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基线，第 24 周
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基于 28 关节计数和高灵敏度 C 反应蛋白 (DAS28-hsCRP) 的疾病活动评分相对于基线的变化
大体时间：基线，第 24 周
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疾病活动评分 (DAS) 修改为包括 28 个关节计数 (DAS28)，由以下变量的综合评分组成：压痛关节计数 (TJC28)、肿胀关节计数 (SJC28)、C 反应蛋白 (CRP)（毫克/升） )，以及患者对疾病活动的整体评估。
使用以下公式计算 DAS28：DAS28-CRP=0.56*square
根 (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*自然
log(CRP+1)+0.014*患者的
全球 VAS+0.96。
分数范围为 1.0-9.4，
其中较低的分数表示较少的疾病活动。
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基线，第 24 周
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修改后的 Total Sharp Score (mTSS) 相对于基线的变化
大体时间：基线，第 24 周
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使用 mTSS (van der Heijde 2000) 对手/手腕和脚的 X 射线进行结构进展评分。 该方法量化了 44 和 42 个关节的骨质侵蚀和关节间隙变窄的程度，分数越高表示损伤越大。 一个时间点的 mTSS 是侵蚀（范围从 0 到 280）和 JSN（范围从 0 到 168）得分的总和，最高得分为 448。 |
基线，第 24 周
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简化疾病活动指数 (SDAI) 得分≤3.3 的参与者百分比
大体时间：第 24 周
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SDAI 是一种用于测量 RA 疾病活动的工具，它集成了 TJC28、SJC28、使用 C 反应蛋白（毫克/升）的急性期反应、使用 VAS 厘米 (cm) 的患者对疾病活动的整体评估以及医生对疾病的整体评估使用 VAS 的活动 (cm)。
SDAI 是通过将 5 个分量的值相加计算得出的。
较低的分数表示较少的疾病活动。
基于指数的缓解定义发生在 SDAI 评分≤3.3 时。
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第 24 周
|
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达到美国风湿病学会 50% (ACR50) 响应的参与者百分比
大体时间：第 12 周、第 24 周、第 52 周
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ACR50 反应指数是 RA 临床、实验室和功能指标的综合。 “ACR50 响应者”是指在压痛和肿胀关节计数方面至少有 50% 改善并且符合以下 5 项标准中的至少 3 项的参与者：医生对疾病活动的全面评估、患者对疾病活动的全面评估、HAQ-DI、关节炎引起的疼痛和 hsCRP。
反应缺失的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
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第 12 周、第 24 周、第 52 周
|
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达到美国风湿病学会 70% (ACR70) 响应的参与者百分比
大体时间：第 12 周、第 24 周、第 52 周
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ACR70 反应指数是 RA 临床、实验室和功能指标的综合。 “ACR70 响应者”是指在压痛和肿胀关节计数方面至少有 70% 改善并且符合以下 5 项标准中至少 3 项的参与者：医生对疾病活动的全面评估、患者对疾病活动的全面评估、HAQ-DI、关节炎引起的疼痛和 hsCRP。
反应缺失的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
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第 12 周、第 24 周、第 52 周
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|
临床疾病活动指数 (CDAI) 评分相对于基线的变化
大体时间：基线，第 24 周；基线，第 52 周
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CDAI 是一种用于测量 RA 疾病活动的工具，不需要实验室组件，并由调查站点进行评分。
它整合了 TJC28（得分 0-28，得分越高表明疾病活动度越高）、SJC28（得分 0-28，得分越高表明疾病活动度越高）、患者疾病活动度的整体评估（在 0-10 厘米的视觉模拟量表上得分）分数越高表明疾病活动性越高），以及医生对疾病活动性的整体评估（在 0-10 厘米的视觉模拟量表上评分，分数越高表明疾病活动性越高）。
CDAI 是通过将 4 个分量的值相加来计算的。
CDAI分数范围从0到76；较低的分数表示较低的疾病活动。
与基线相比的负变化表明状况有所改善。
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基线，第 24 周；基线，第 52 周
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疾病活动评分 28-红细胞沉降率 (DAS28-ESR) 相对于基线的变化
大体时间：基线，第 24 周；基线，第 52 周
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DAS28 由以下变量的综合评分组成：压痛关节计数 (TJC28)、肿胀关节计数 (SJC28)、红细胞沉降率 (ESR)（毫米/小时）和患者的疾病活动总体评估。
使用以下公式计算 DAS28：DAS28-ESR=0.56*square
根 (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*自然
log(ESR)+0.014*患者的
全球增值服务。
分数范围为 1.0-9.4，
其中较低的分数表示较少的疾病活动。
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基线，第 24 周；基线，第 52 周
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达到美国风湿病学会/欧洲抗风湿病联盟 (ACR/EULAR) 缓解的参与者百分比
大体时间：第 12 周、第 24 周、第 52 周
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RA 缓解的 ACR/EULAR 定义包括“基于布尔的定义”。
当在同一次就诊时满足以下所有 4 个标准时，即出现基于布尔值的缓解定义：TJC28 ≤1，SJC28 ≤1，使用 C 反应蛋白（毫克/分升）的急性期反应≤1，患者对使用 VAS 的疾病活动度 (cm) ≤1。
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第 12 周、第 24 周、第 52 周
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|
关节间隙缩小和骨侵蚀评分相对于基线的变化
大体时间：基线，第 24 周；基线，第 52 周
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评估手/手腕和脚的 X 射线是否有关节间隙变窄 (JSN) 和骨侵蚀。
每只手（每只手 15 个关节）和每只脚（每只脚 6 个关节）的 JSN 评估，包括半脱位，评分从 0 到 4，0 表示没有（正常）JSN，4 表示关节间隙完全丧失，骨性强直或脱位。
JSN 分数范围为 0-168。
0 分表示没有变化，较高的分数表示关节间隙变窄的恶化。
骨侵蚀评分是对手部 32 个关节和脚部 12 个关节的侵蚀严重程度的总结。
每个关节根据涉及的表面积进行评分，手关节为 0 到 5，足关节为 0 到 10，0 表示没有侵蚀，最高分（手为 5，足为 10）表示广泛损失骨由超过一半的关节骨组成。
侵蚀分数范围从 0（无侵蚀）到 280（高侵蚀）。
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基线，第 24 周；基线，第 52 周
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清晨关节僵硬持续时间相对于基线的变化
大体时间：基线，第 52 周
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参与者以小时和分钟为单位报告了他们早晨关节僵硬 (MJS) 的持续时间。
参与者在研究访问前一天被问及他们早晨关节僵硬的持续时间以捕捉实际症状，因为参与者在研究访问当天可能有不典型的早晨例程。
如果早晨关节僵硬持续时间超过 12 小时（720 分钟），则将其截断为 720 分钟以进行统计展示和分析。
早晨关节僵硬持续时间的减少表明参与者的状况有所改善。
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基线，第 52 周
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最严重疲劳数字评定量表 (NRS) 相对于基线的变化
大体时间：基线，第 24 周；基线第 52 周
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参与者通过从 0 到 10 中选择一个最能描述他们在过去 24 小时内最严重的疲劳程度的数字来评估他们的疲劳程度，其中 0 代表“没有疲劳”，10 代表“你能想象到的最糟糕”。
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基线，第 24 周；基线第 52 周
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最严重关节疼痛数值评定量表 (NRS) 相对于基线的变化
大体时间：基线，第 24 周；基线第 52 周
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参与者通过从 0 到 10 中选择一个最能描述他们在过去 24 小时内最严重的关节疼痛的数字来评估他们的关节疼痛，其中 0 代表“没有疼痛”，10 代表“你能想象到的疼痛程度”。
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基线，第 24 周；基线第 52 周
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医疗结果研究 36 项简短健康调查第 2 版（SF-36v2 急性）的心理成分评分 (MCS) 和身体成分评分 (PCS) 相对于基线的变化
大体时间：基线，第 24 周；基线第 52 周
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SF-36 是一项评估参与者生活质量的健康相关调查，由 36 个问题组成，涵盖 8 个健康领域：身体机能、身体疼痛、身体问题和情绪问题导致的角色限制、一般健康、心理健康、社会功能、活力和 2 个分量分数（MCS 和 PCS）。
MCS 包括社会功能、活力、心理健康和角色情绪量表。
PCS 包括身体机能、身体疼痛、身体角色和一般健康量表。
每个领域的评分是通过将各个项目相加并将分数转换为 0 到 100 的等级，分数越高表示健康状况或功能越好。
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基线，第 24 周；基线第 52 周
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欧洲生活质量基线的变化 - 5 个维度 - 5 个级别 (EQ-5D-5L) 分数
大体时间：基线，第 24 周；基线第 52 周
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European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) 是衡量参与者健康状况的标准化指标。
其中一个组成部分包括一个描述受访者健康状况的系统，该系统由以下 5 个参与者报告的维度组成：行动能力、自我保健、日常活动、疼痛/不适和焦虑/抑郁。
每个维度有5个等级：没有问题、轻微问题、中度问题、严重问题和极端问题。
这些回答用于使用英国 (UK) 算法和美国 (US) 算法得出健康状况指数得分，得分范围为 -0.594 至 1，得分范围为 -0.109 至 1。
分数越高表明健康状况越好。
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基线，第 24 周；基线第 52 周
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欧洲生活质量基线的变化 - 5 个维度 - 5 级 (EQ-5D-5L) 分数（自我感知健康）
大体时间：基线，第 24 周；基线第 52 周
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EQ-5D-5L 的第二个组成部分是自我感知的健康评分，使用 VAS 进行评估，范围从 0 到 100 毫米 (mm)，其中 0 表示您可以想象的最差健康状况，100 表示您认为最好的健康状况可以想象。
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基线，第 24 周；基线第 52 周
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慢性疾病治疗疲劳功能评估 (FACIT-F) 评分相对于基线的变化
大体时间：基线，第 24 周；基线第 52 周
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慢性疾病治疗疲劳功能评估 (FACIT-F) 量表是一个包含 13 个项目的针对特定症状的问卷，专门评估参与者自我报告的疲劳严重程度及其对日常活动和功能的影响。
FACIT-F 对每个项目使用 0（“完全没有”）到 4（“非常多”）的数字评分量表来评估过去 7 天的疲劳及其影响。
总分范围从 0 到 52，分数越高表明疲劳程度越低。
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基线，第 24 周；基线第 52 周
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工作效率和活动障碍-类风湿性关节炎 (WPAI-RA) 评分相对于基线的变化
大体时间：基线，第 24 周；基线第 52 周
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开发了工作效率和活动障碍-类风湿性关节炎 (WPAI-RA) 调查问卷，以测量就诊前 7 天总体健康状况和症状严重程度对工作效率和常规活动的影响。
它包含 6 个项目，涵盖整体工作效率（健康）、整体工作效率（症状）、日常活动障碍（健康）和日常活动障碍（症状）。
分数按减值百分比计算。
WPAI-RA 产生四种类型的分数：旷工（错过工作时间）、出勤率（工作受损）、工作效率损失（整体工作受损）和活动受损。
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基线，第 24 周；基线第 52 周
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群体药代动力学 (PK)：Baricitinib 的稳态峰浓度 (Cmax,ss)
大体时间：第 0 周：给药后 15 和 60 分钟；第 4 周：给药后 2 至 4 小时；第 8 周：给药后 4 至 6 小时；第 12 周；第 24 周；第 32 周；给药前
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第 0 周：给药后 15 和 60 分钟；第 4 周：给药后 2 至 4 小时；第 8 周：给药后 4 至 6 小时；第 12 周；第 24 周；第 32 周；给药前
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群体 PK：Baricitinib 稳态给药间隔 (AUCtau,ss) 下浓度与时间曲线下的面积
大体时间：第 0 周：给药后 15 和 60 分钟；第 4 周：给药后 2 至 4 小时；第 8 周：给药后 4 至 6 小时；第 12 周；第 24 周；第 32 周；给药前
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第 0 周：给药后 15 和 60 分钟；第 4 周：给药后 2 至 4 小时；第 8 周：给药后 4 至 6 小时；第 12 周；第 24 周；第 32 周；给药前
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
- Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
- van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.
- Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.
- Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.
- Taylor PC, Alten R, Alvaro Gracia JM, Kaneko Y, Walls C, Quebe A, Jia B, Bello N, Terres JR, Fleischmann R. Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy. RMD Open. 2022 Mar;8(1):e001994. doi: 10.1136/rmdopen-2021-001994.
- Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
- Schiff M, Takeuchi T, Fleischmann R, Gaich CL, DeLozier AM, Schlichting D, Kuo WL, Won JE, Carmack T, Rooney T, Durez P, Shaikh S, Hidalgo RP, van Vollenhoven R, Zerbini CAF. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.
- Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (实际的)
2015年2月1日
研究完成 (实际的)
2015年8月1日
研究注册日期
首次提交
2012年10月18日
首先提交符合 QC 标准的
2012年10月18日
首次发布 (估计)
2012年10月22日
研究记录更新
最后更新发布 (实际的)
2019年9月19日
上次提交的符合 QC 标准的更新
2019年9月9日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 14062
- I4V-MC-JADZ (其他标识符：Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。
IPD 共享时间框架
在美国和欧盟研究的适应症首次公布和批准后 6 个月（以较晚者为准）可提供数据。
数据将无限期地可供请求。
IPD 共享访问标准
研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.